The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthccs.
| Device ID | K172983 |
| 510k Number | K172983 |
| Device Name: | HealthCCS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim, IL 6099000 |
| Contact | Matan Neeman |
| Correspondent | Flair Bar Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim, IL 6099000 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018016008 | K172983 | 000 |